Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on Postoperative Pain After Video-assisted Thoracoscopic Surgery

Not Applicable

Not yet recruiting

• Conditions: Postoperative Pain; Video-assisted Thoracoscopic Surgery (VATS)

• Registration Number: NCT06744166
• Lead Sponsor: Changhai Hospital

Brief Summary

At present, surgical resection remains one of the main methods for the radical treatment of lung cancer. Compared with traditional thoracotomy, Video-assisted Thoracoscopic Surgery (VATS) offers obvious advantages, such as less surgical trauma and rapid postoperative recovery. However, a certain proportion of patients will still experience moderate to severe pain after undergoing VATS. Postoperative acute pain can lead to increased postoperative pulmonary complications, prolonged hospital stays, and increased treatment costs. Additionally, it is also associated with the development of postoperative chronic pain. Therefore, effective pain management after VATS is crucial.

Researchers will compare Transcutaneous Electrical Nerve Stimulation (TENS) based on Wrist-Ankle Acupuncture theory (TENS-WAA) with a sham stimulation regimen to determine whether TENS-WAA can relieve postoperative pain in patients undergoing thoracoscopic lung resection. This study aims to enrich the existing postoperative analgesia schemes and provide a reliable basis for its clinical promotion.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-20
• Last Update Submitted: 2025-02-05
• Study Start: 2025-02-06
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• Patients aged over 18 years
• American Society of Anesthesiologists (ASA) physical status of I-III
• Patients scheduled for elective unilateral lobectomy via video-assisted thoracoscopic surgery (VATS) for lung cancer under general anesthesia
• Informed consent signed

Exclusion Criteria

• History of liver, kidney, heart, lung, or brain disease
• Psychiatric disorder or cognitive impairment
• Chronic pain, daily use of analgesics, or alcohol dependence
• Routine or recent acupuncture treatment
• Contraindications to TENS (with pacemaker or metallic implants, allergy to surface electrodes, with skin sensory disorders, skin ulceration, unhealed scars, or adhesions)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The dynamic VAS score	at 24 hours after surgery	Independent investigators will assess the postoperative dynamic pain (pain during activities or coughing) by utilizing a visual analogue scale (VAS) ranging from 0 to 10. The two ends of the straight line represent "no pain at all" and "the worst pain imaginable," respectively. Patients are required to mark their corresponding position on the line based on their perception of pain, and the numerical value corresponding to this position serves as the patient's pain score.

Secondary Outcome Measures

Name	Time	Method
The static VAS score	at 6 hours, 12 hours, 24 hours and 48 hours after surgery	Postoperative static pain (pain at rest) will be quantified using the VAS.
The dynamic VAS score	at 6 hours, 12 hours and 48 hours after surgery	Postoperative dynamic pain (pain during activities or coughing) will be quantified using the VAS.
Opioid consumption during surgery	at the end of the surgery	The consumption of opioids during the surgery will be converted into morphine equivalent, and then the total will be calculated.
Postoperative opioid consumption	at 48 hours after surgery	The consumption of opioids within 48 hours after surgery will be converted into morphine equivalent.
Consumption of NSAIDs	at 48 hours after surgery	The consumption of Non-steroidal Anti-inflammatory Drugs within 48 hours after surgery will be recorded.
The 15-item QoR score	at 24 hours and 48 hours after surgery	The 15-item QoR score is used to assess the quality of recovery after surgery, which ranges from 0 to 150, and higher QoR-15 scores indicate better postoperative recovery.
The HADS score	at 24 hours and 48 hours after surgery	The Hospital Anxiety and Depression Scale (HADS) is used to evaluate patients' anxiety and depression. Scores on the HADS range from 0 to 21, and higher scores indicate more severe anxiety or depression.
The AIS score	The morning of the first day after surgery and the morning of the second day after surgery.	The Athens Insomnia Scale (AIS) is used to assess the quality of sleep after surgery. Scores on the AIS range from 0 to 24, and higher scores indicate worse sleep quality.
Incidence of PONV	at 48 hours after surgery	The researchers will observe whether patients experience nausea and vomiting after surgery.
The duration of hospital stay	on the 1 day of the patient's discharge from the hospital	The period from the end of surgery to the patient's discharge from the hospital will be recorded.

Trial Locations

Locations (1)

Changhai hospital; 🇨🇳 Shanghai, Shanghai, China